Norway 'excellent example' of how to increase access to biosimilars
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The European Union, and specifically Norway, has demonstrated successful strategies for making biosimilars available for patients — and realizing “tremendous savings” — that should be adopted in the United States, according to an analysis.
“With exception of the Kaiser Permanente health system and U.S. Veterans Affairs, biosimilars have not been widely adopted in the United States, due to patent issues — use patents are relevant only in the United States — lawsuits — such as the recently settled Pfizer versus Janssen lawsuit over the former’s infliximab biosimilar — and payer reluctance — no incentives,” Vibeke Strand, MD, MACR, FACP, an adjunct clinical professor at Stanford University, in Palo Alto, California, and one of the authors of the analysis, told Healio.
“The Norwegian national tender system is an excellent example of how cost savings can be realized by the requirement that each company offer a price for their product, and the tremendous savings realized from using biosimilars,” she added.
EU ‘Leading the Way’ for Biosimilars
Published in Seminars in Arthritis and Rheumatism, the analysis reviews the current obstacles to increased biosimilar availability in the United States and details the strategies used to improve their uptake in the European Union.
According to the authors, the European Union is “leading the way” in biosimilar approvals, use and cost savings. As of September 2021, 80 biosimilars have been approved in Europe, compared with 31 in the United States. Incentive programs established by individual EU member states, health authorities and payers in recent years has led to a significant increase in biosimilar use in Europe, they wrote.
In one example, Strand and colleagues describe how strong financial incentives for switching in Norway have resulted in 80% market shares for epoetin’s (Epogen, Amgen; Procrit, Janssen) and filgrastim’s (Neupogen, Amgen) biosimilars, with higher market shares for biosimilar TNF inhibitors. Meanwhile, in the United States, biosimilars accounted for just 2% of the $126 billion spent on biologics in 2018.
The authors also described Norway’s national tender system for biologics, in which each company offers a price for its product. As these treatments demonstrate similar efficacy and safety on a group level, cost becomes the major determinant for use, they wrote.
“The budget for the cost of these drugs is now within the hospital system (biosimilars were covered by general reimbursement when they first launched), which enhances loyalty to the system,” Strand and colleagues wrote. “This system has created increased competition that has impacted the uptake of biosimilars.”
For example, when the infliximab (Remicade, Janssen) biosimilar CT-P13 (Remsima, Celltrion; Inflectra, Pfizer) became available there in 2014, its price was as much as 39% lower than the originator product. One year later, it was 69% lower. In addition, data reveal that access to many biosimilars in Norway have increased substantially — 100% for infliximab products from 2015 to 2021, more than 200% for adalimumab (Humira, AbbVie) biosimilars from 2018 to 2021, and 50% for etanercept (Enbrel, Amgen) biosimilars from 2016 to 2021.
Total cost has decreased by about $80 million, Strand and colleagues wrote.
Unique Barriers Stateside
According to the review authors, obstacles to biosimilar uptake in the United States include reimbursement policies in which biosimilars, with their lower average sales price, deliver lower reimbursement than their reference products. In addition, some pharmacy benefit managers enter agreements in which they receive high rebates for using reference products.
“Once this happens, they are vested in dispensing the reference product and have a reduced financial incentive to offer the less expensive biosimilar,” the authors wrote. “To prevent providers from facing this financial deterrent to prescribe lower-cost biosimilars, insurance programs have changed reimbursement policies to aggressively incentivize biosimilars through payment.”
Other common hurdles have also included extensive patent litigation, which has delayed the introduction of all but a few biosimilars into the U.S. marketplace, and physician and patient concerns over switching.
According to the review, one health care system in the United States has in fact had success in enjoying the benefits of biosimilars: Kaiser Permanente. This success is based on declining to accept rebates and proactively addressing provider concerns regarding biosimilar safety and efficacy, the authors wrote.
The U.S. government can also increase healthy price competition by following the examples given by the European Union and Norway, which have successfully controlled costs and promoted biosimilar uptake, they added.
“The successful example from the Norwegian system in terms of cost savings, including earlier initiation of biologic therapy in RA, show why we need such means to adopt equivalent therapies of significantly lower cost,” Strand said. “How well this has worked in the Kaiser system, and in more limited fashion in the VA, show why we need to fight these ridiculous use patents and be allowed to prescribe biosimilar adalimumab and etanercept products.”
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